Home NDC 66689-008 Nystatin
Product NDC 66689-008
11-digit product format 666890008
Labeler code 66689
Product ID 66689-008_beaf5815-9659-4ba3-ac23-6e734f4afc05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nystatin
Dosage form SUSPENSION
Route ORAL
Labeler VistaPharm, Inc.
Application ANDA064142
Marketing category ANDA
Marketing start 2012-05-01
Marketing end 0000-00-00
Substance NYSTATIN
Active strength 100000 [USP'U]/mL
Pharmacologic classes Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A064142-001 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 A064142-002 NYSTATIN NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 70 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 1998-06-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL 2011-03-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064142-002 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 2011-03-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064142-001 NYSTATIN 100,000 UNITS/ML SUSPENSION / ORAL AA 1998-06-25 3f01610625f2…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Carboxymethylcellulose Sodium INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Saccharin Sodium Dihydrate INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Sodium Phosphate, Dibasic, Anhydrous INACTIVE INGREDIENT 22ADO53M6F NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Sodium Phosphate, Monobasic, Monohydrate INACTIVE INGREDIENT 593YOG76RN NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [VISTAPHARM, INC] 3 Nystatin ACTIVE INGREDIENT BDF1O1C72E NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Nystatin ACTIVE MOIETY BDF1O1C72E NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Alcohol INACTIVE INGREDIENT 3K9958V90M NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Carboxymethylcellulose Sodium INACTIVE INGREDIENT K679OBS311 NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Saccharin Sodium Dihydrate INACTIVE INGREDIENT SB8ZUX40TY NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Sodium Phosphate, Dibasic INACTIVE INGREDIENT GR686LBA74 NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Sodium Phosphate, Monobasic INACTIVE INGREDIENT 3980JIH2SW NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Sucrose INACTIVE INGREDIENT C151H8M554 NYSTATIN SUSPENSION [VISTAPHARM INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R NYSTATIN SUSPENSION [VISTAPHARM INC.] 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66689-008-02 66689000802 60 mL in 1 BOTTLE (66689-008-02) 60 ml 2012-05-01 0000-00-00 No No Current 66689-008-08 66689000808 237 mL in 1 BOTTLE (66689-008-08) 237 ml 2012-05-01 0000-00-00 No No Current 66689-008-16 66689000816 480 mL in 1 BOTTLE (66689-008-16) 480 ml 2012-05-01 0000-00-00 No No Current